FDA Just Issued "A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers Guidance for Industry". FDA Is Accepting Your Comments
Participation is a right! Use it or lose it!
This guidance provides information on risk-based approaches to monitoring the conduct of clinical investigations of human drug and biological products, medical devices, and combination products. Clinical investigation monitoring is a quality control tool for determining whether investigation activities are being carried out as planned. This guidance contains recommendations on planning a monitoring approach, developing the content of a monitoring plan, and addressing and communicating monitoring results. This guidance expands on the guidance for industry Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring (August 2013) by providing additional information to facilitate sponsors’ implementation of risk-based monitoring.
Download Guidance Here:
One point that stands out is:
“Should the risk-based monitoring approach include processes to ensure that appropriate blinding is maintained?”
Yes.
OK everyone, the real question is: “are Pfizer and the Pharma Sponsors ever going to be held to these standards?”
Let us remember, the FDA Guidance is merely “recommended” and it’s apparently up to the criminal Pharma Sponsors to follow it or not. “In general, FDA’s guidance documents do not establish legally enforceable responsibilities.”
Submit Comments
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852All written comments should be identified with this document's docket number: FDA-2019-D-0362.
This entire endeavor is an objectively illegitimate manipulation that has no impact or significance anyway.
SARS-CoV-2 is not a "novel zoonotic coronavirus." It is a biologically engineered bioweapon with the people as the target. Your opinion and input is not wanted or needed, however, your identifying information may have some value to them.
Ummm... how about starting with core systemic industry issues first that, until fixed, will render "monitoring" the conduct of anything a complete pipe dream AT BEST. How about starting with issues like agency capture by the very industry our current health agencies are supposed to be regulating. And the financial "incentives" racket that have corrupted the entire health regulation industry. Or how about issues like the revolving door phenomenon that plague the regulatory process? And while we're at it, until this cesspool of corruption is completely cleaned out, overhauled and rebuilt from scratch, how about any and all future "monitoring' be conducted by a temporary, uncaptured and fully-transparent oversight committee THAT ACTUALLY REPRESENTS THE INTEREST OF HEALTH, SCIENCE AND WE THE PEOPLE?! And how about starting with the actual ROOT PROBLEMS instead of trying to polish a turd with a band aid? Here's my prescription for A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers Guidance for Industry: Start by firing EVERYONE at the FDA and CDC (starting with that evil witch, Rochelle Walensky), gut the entire current incarnation of each of these rotten-to-the-core, corrupt agencies and then START OVER. With new, updated laws, industry regulations and quarterly audits by WE THE PEOPLE. Problem solved. Next?